Unsigning

Thanks to AndyPR for this information about how to ‘unsign’ from the MEGA petition if you signed but are now having second thoughts due to the involvement of Profs White & Crawley etc.

“If people have signed this Mega Research Project Petition …unaware of the PACE exponents’ involvement …if they wish to UNSIGN pending further clarification of patient selection criteria, data sharing protocols, and exactly how the PACE experts are involved in the study…..
Go to your confirmation e.mail and press the “didn’t sign” text box and that will remove your name.

“If you have lost or deleted the original email confirmation, you can also fill in a form on the Change org web page and request to be removed. They will do so and confirm it.”

White In Denial

We’ve had to put up with decades of nonsense about ME in the press but today’s Guardian article by Peter White of the PACE Trial has to be the worst I’ve seen. It wasn’t easy to leave a comment on the article while shaking with anger but I did my best. Here’s what I wrote. I’m pleased to say that many others were making powerful points at he same time.

Following the recent release of data from Peter White’s PACE trial (by order of a Freedom of Information tribunal, £250,000 having been spent in attempting to stop it) PACE has finally been revealed as the travesty of the truth it always has been. Rather than give the appropriate heartfelt apology, however, Prof White continues in denial.

The blog to which he disparagingly refers was written by patients who have used energy they can ill afford to spend in a David-and-Goliath struggle to reveal the truth about this reprehensible study. With the aid of expert statisticians they have not distorted the figures, as Prof White implies. What they have done is to use the newly released data to analyse the results in line with the trial’s original protocol, which White and his fellow authors originally declared they would use but then changed their minds as it didn’t give them the outcomes they wanted. They never gave a satisfactory explanation for this change but it now seems pretty obvious why it happened. The newly reanalysed results show that GET and CBT are of no more use than a placebo. They are worthless for ME/CFS, but White and his associates refuse to admit it as they have built their life’s work on these therapies. Therapies which, moreover, have been shown to be harmful for patients with ME/CFS in numerous surveys. Patients have ended up housebound or bedbound for years on end because of the efforts of White & Co, but still they refuse to admit they have done anything wrong.

This change of protocol was only the tip of the iceberg in terms of the study’s shortcomings. The Criteria used to select subjects for the study included patients with other fatigue conditions; the numerous changes in protocol meant that patients could be ill enough to join the study, deteriorate during it, yet still be classed as ‘recovered’ at the end; objective outcome measures which actually measured patients’ abilities were abandoned in favour of questionnaires; conflicts of interest on the part of the investigators were not disclosed to study participants, the list goes on and on…. In years to come, PACE will be used as an example of how NOT to conduct a research study.

 

P.S. The most complete analysis of the many shortcomings of the PACE trial is by David Tuller. The article, Trial By Error,  is in several parts. There are links to all of them here. If you just read the summary though, at the opening of part one, that tells you a lot.

MEGA Petition

Here is a copy of an email from Leeds ME Network sent to Sonya Chowdhury, CEO of Action for ME concerning the petition which she has been circulating regarding the proposed ‘big data’ study by the UK CFS/M.E. Research Collaborative. It is another situation, similar to the NIH study in the US – where the research sounds very promising but some of the personnel involved sound alarm bells. Leeds ME Network are therefore requesting more details and – hopefully – reassurances.

Dear Sonya – I am writing because I find it difficult to know how to respond to the MEGA petition which you have been promoting. Of course I am in favour of more biomedical research into ME. Normally I would sign this petition, circulate it to our members, and publicise it more widely on social media. Yet I am concerned about the presence of  Profs White and Crawley in the MEGA team. I am sure you are aware that many other patients share my reservations.

Following the recent release of data, it is now clear that Prof White and his PACE team deliberately manipulated the data to get the result they wanted, thereby deceiving patients, doctors, and decision makers both in this country and worldwide, Action for ME included. I know that your predecessor, Sir Peter Spencer, expressed surprise at the results of the PACE Trial. Well he might have done, because it is now clear that the published results were a travesty of the truth.

As for Prof Crawley, as you will be aware she is now about to test GET on children in the MAGENTA trial (in spite of widespread concerns about the PACE trial plus substantial reporting by patients of harms from this therapy), has recently been testing the quack therapy the Lightning Process on children, and has added to the substantial body of misinformation about ME by conducting a study of the prevalence of CFS at age 16 by using subjects who were ‘diagnosed’ by questionnaire and without the involvement of doctors.

In view of these issues. I’m afraid I have no confidence in any research involving either Profs White or Crawley and am therefore loath to sign or distribute the petition. But on the other hand, I would very much like to support biomedical research. I therefore feel I am caught between a rock and a hard place and it seems that many other patients feel the same.

I notice that ME Research UK have put a slightly different list on their web site: a ‘main MEGA team’ which does not include Profs White and Crawley. This makes perfect sense, as it is hard to see why either of them, given their skill sets and the nature of their previous work, should be involved in biomedical research anyway. So I wonder if their presence on the petition page is a token one only, acknowledging their membership of the Research Collaborative perhaps? If this were the case, if Profs White and Crawley were not actually to be involved in the big data project (and therefore not at liberty to subvert it), I might well feel able to support and publicise the petition. I wonder if you are able to advise me on this or else pass this email on to someone else who can?

I have just being listening to your presentation at the Research Collaborative conference in which you spoke very tellingly of the need for an appropriate level of funding for ME research. I am grateful to you for making this case and am sorry if you feel that I – and perhaps others – are ‘shooting ourselves in the foot’ by expressing such reservations about who is in charge of research. But experience has taught us that bad research is even worse than no research. The efforts of Prof White and the biopsychosocial school have been one of the main factors in reducing investment in biomedical research in recent years. It has taken patients many years – and a lot of energy we could ill afford to spend – to get to the stage where we are finally starting to expose the PACE Trial for the sham that it is. We cannot afford for the same thing to happen again.

 Note: I’ve been asked to include details of ‘unsigning’ in case you previously signed the MEGA petition and wish to un-sign pending further information about the study. I covered it here

A Few Notes on GETSET

The latest GET study by Prof Peter White et al is entitled Graded Exercise Therapy guided Self-help Treatment (GETSET) for patients with chronic fatigue Syndrome: a randomised controlled trial in secondary care. This trial apparently aimed to assess the efficacy and safety of Guided Exercise Self-help (GES). At the time of writing, an abstract only is available and this has been discussed on the Phoenix Rising forum. Russell Fleming summarised some of the discussion in a useful series of tweets and I asked his permission to share them here, not least because tweets are such ephemeral things and can be hard to access for future reference.

Russell frequently tweets extremely useful summaries of new research papers and notable ME-related events and is well worth following if you don’t already do so. Follow him @Firestormmer

Here are Russell’s notes on GETSET. (Whatever you think of the research, you have to admire the acronyms, though someone on Phoenix Rising suggested that GETSHT might be more appropriate.) Over to Russell:

From the discussion on Phoenix Rising and without anyone seeing the full paper, there already appears to be some issues with this trial. Quelle surprise you might think. Let me try to summarise the concerns:

1.The Chalder fatigue scale outcome was added after the trial started.

2. The NICE criteria were used to recruit but from selected secondary care centres – we don’t yet know which ones but can probably guess.

3. Only after the trial was an attempt made to allocate patients to other criteria and only Fukuda and Oxford – e.g. no mandatory PEM

4. The trial ran for only 12 weeks – which might be a fair representation of secondary care – but may not be long enough.

5. The improvements are ‘tiny’ e.g. A CFQ 6.3 point improvement means patients marked one question one step better than at baseline.

6. They also only list “adjusted” scores, so unadjusted scores probably show no improvement.

7. Serious adverse events were recorded in each arm (1% GET, 2% SMC) but we don’t know what their definition was from the abstract.

8. The pre-specified outcome measure (SF36) recorded only small effect size, so they switched to Chalder post-hoc for a better result.

9. The end-date for the trial was extended and more patients recruited while the trial was underway. This would affect outcome measures.

10. There’s mention in the Phoenix Rising discussion of a 1 year outcome measure (Chalder) but I can’t see the results in the abstract.

11. “It’s interesting how they extended the judgment period and used an additional primary outcome after the original end of the trial.”

12 There was no control group used in the trial. These authors do not appear to have learned anything from past endeavours.

Note: It amazes me that they have the cheek to conclude these measly effect sizes as ‘moderate’. What on earth would they be for recovery?!

– Russell Fleming

Door to Freedom Revisited

Following my earlier post about the tenuous argument put forward for the recent PACE Trial Freedom of Information Act refusal, I’ve been digging a bit deeper and I think it is now absolutely clear that the ‘evidence’ cited in the refusal notice totally fails to support QMUL’s case. It also appears that it has been deliberately quoted out of context by QMUL to create a misleading impression.

Just to remind you, here is my summary of the argument used for refusing the request:

“The argument seems to go like this: in spite of the fact that this specific request is not onerous and in spite of the fact that the complainant has not previously made an FOI request, he has been adjudged to be part of a coordinated campaign to discredit PACE (because he has talked to other people about PACE on the internet). Therefore the issue has been judged not on this specific request but on the overall burden of PACE-related FOI requests on QMUL, which are accepted not to be overwhelming but have nevertheless caused ‘disproportionate irritation and stress’ to Prof White and his team and are therefore vexatious. Therefore the request for this important piece of information is refused.”

What got me looking at things more closely was this comment by Chrisb on the Phoenix Rising forum in response to my post:

“Mr Spoonseeker has referred to and dealt with the point about the sheer weight of requests but I think there is another point.

“The Guidance apparently states that “if a public authority has reason to believe that several different requesters are acting in concert as part of a campaign to disrupt the organisation by virtue of the sheer weight of FOIA requests being submitted……”

“This guidance appears to be primarily, and quite reasonably, directed at and applicable to an entirely different type of campaign where the object is to bring about the disruption of the organisation, rather than a bona fide attempt to obtain information. Has any evidence been presented with the purpose of demonstrating that the requesters intent was disruption of the organisation of QMUL rather than obtaining the information which we believe to be the real object of the request?

“Given the Commissioner’s acceptance that this particular request on its own would not impose a significant burden, the onus of proof to establish whether the person was acting in concert with others, whose intent was disruption, ought to be significantly higher.

“In order to show that the request constituted part of a campaign one might expect it to be necessary to adduce evidence of a campaign predating the request. It seems to me that the examples quoted by QMUL probably were made after the request and in response to the initial refusal. Alternatively one might attempt to show a link to subsequent requests, but as I recall it there was no such attempt.”

In actual fact I had attempted to deal with most of this issue in my earlier post as follows: Continue reading “Door to Freedom Revisited”

Closing the Door on Freedom

OK, here’s my take on the Freedom of Information Refusal Notice which came out a couple of days ago, not to be confused with the Tribunal outcome which (as I write) is expected imminently. Apologies for the fact that it’s about twice as long as it should be but I now have brain fog so I don’t have the intellect to edit it down! If you manage to read it, I hope you find it of interest. Me, I’m going to get some sleep….

The latest PACE Trial Freedom of Information Refusal Notice causes particular concern, not only for the PACE Trial and its implications for the future prospects of people with ME/CFS, but also for the Freedom of Information Act itself – and even for freedom of speech. The Notice incorporates twelve pages of repetitive arguments from QMUL (Queen Mary University of London, home of the PACE Trial) and three pages of what seem to me to be concise and clearly argued response from ‘the complainant’ (i.e. the guy who has made the request for information). Unfortunately, the Commissioner then goes on to reject the latter in favour of the former, apparently believing every word that QMUL have told him, i.e. that patients have launched a concerted campaign to discredit the PACE Trial by submitting a burdensome number of FOI requests in the desperate hope of finding something wrong with it and in the meantime bringing Lead PACE Investigator Prof Peter White and his staff to their knees under the resultant administrative load so that they aren’t able to do any more of their vital research. Or something like that. Their evidence is not so much a linear argument as a trip several times round the houses in the hope that if they say the same things often enough, some of them will eventually convince the Commissioner. Unfortunately, this strategy appears to have been successful.

The information the complainant requested relates to the data from the step test, an objective outcome measure which went unreported in the original PACE report but appeared in the form of a small scale graph in an appendix to one of the follow up studies. Continue reading “Closing the Door on Freedom”

Make Sure We Speak

After a difficult few weeks in the world of ME advocacy, it’s been really heartening to see the new critique of the PACE trial and accompanying editorial on the Sense About Science USA/ American Statistical Association website. After 7000 words of searing analysis, Rebecca Goldin concludes that the flaws in the study design “were enough to doom its results from the start”, while Trevor Butterworth’s editorial pronounces “a terminal prognosis” on the study. As far as patients are concerned, this demise cannot come too soon – and it remains to be seen if the British media, who have uncritically lauded the study on so many occasions, will consider this latest development to be worth reporting.

Nevertheless, it is encouraging for patients to receive such clear validation of what we have been saying for so long from such a reliable source. It has to be another important step in the right direction.

Trevor Butterworth writes: “David Tuller may not get a Pulitzer Prize for investigating PACE trial on a blog; but his service to—and we do not exaggerate—millions of sufferers around the world make it hard for us to think of another work of journalism so deserving of commendation.” Patients – including those who produced the initial critiques which first attracted Tuller to the issue – will heartily agree with that analysis, likewise with Butterworth’s acknowledgement of the important contribution of Julie Rehmeyer in drawing attention to the flaws of the trial. Let us hope their work pays off very soon and the study is deservedly retracted. Lead PACE investigator Peter White still has his finger in the dam but sweat is breaking out on his forehead. He must be wondering how much longer he can hold back the torrent of truth. Continue reading “Make Sure We Speak”